Investigation of a Novel Approach to Improve Adherence to Treatment and Treatment Success Rates for Tuberculosis Patients in Senegal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- TB treatment success rate (cure + completed treatment)
研究概览
简要总结
Tuberculosis (TB) patients who receive inadequate treatment or do not complete therapy are more likely to remain infectious, thus contributing to the continuous spread of TB infection in communities. Despite the widespread use of Directly Observed Therapy, defaulters remain an important problem in TB control programmes. In Sénégal, defaulters rate reach 30%, which is hampering dramatically the effectiveness of control. New strategies to deliver treatment to TB patients and ensure proper adherence that are adapted to the local situations are urgently needed.
Objectives
The overall objective of the project is to improve tuberculosis treatment success rates in Sénégal. The specific objectives are:
- to assess the current situation of tuberculosis (TB) in Sénégal
- to identify the determinants of cure,
- to develop measures to improve patient's compliance with the treatment that are adapted to the local situation, acceptable, affordable and sustainable
- to evaluate the impact of these measures on TB control.
Methods
The proposed research seeks to develop and test innovative methods to improve cure rates in TB patients. It will explore the factors of success of TB treatment using inter-disciplinary approach, integrating social sciences and economic analyses into TB research. The project is composed of 3 comprehensive phases:
- Phase 1: baseline assessment of the TB situation.
- Phase 2: anthropological study, investigating various domains contributing to patients cure using a range of qualitative research methods. At the end of this investigation, it is expected that determinants of care will be clearly identified. On this basis, suitable methods for improving patients' adherence to treatment will be tailored and developed.
- Phase 3: these methods will be tested and compared using a cluster randomised controlled trial design, in populations served by defined health centres. Their efficacy will be measured in terms of improvement of the classical TB control programme indicators (cure rate, defaulter rate, failure rate, death rates). The methods will also be evaluated on their acceptability by the TB patients and the communities and on their feasibility (duration : 24 months).
Expected results:
Methods to improve patients' adherence to treatment that are affordable, acceptable and sustainable will be developed and tested according to qualitative and quantitative criteria.
详细描述
General Project Methods
The proposed research seeks to develop and test innovative methods to improve treatment success rates in TB patients in Senegal. It will explore the factors of success of TB treatment using inter-disciplinary approach, integrating social sciences and economic analyses into TB research. The project is composed of 3 comprehensive phases, that will be run concurrently and complement each other:
- Phase 1: baseline assessment of the TB situation. It is first proposed to assess the magnitude of the TB problem and of the means to control it through a standard baseline assessment (6 months).
- Phase 2: anthropological study, investigating various domains contributing to patients cure (the patients, the community, the general health services, the policy makers and the TB control staff), using a range of qualitative research methods (12 months). At the end of this investigation, it is expected that determinants of care will be clearly identified with a comprehensive understanding of their relation/interface. On this basis, suitable methods for improving patients' adherence to treatment will be developed.
- Phase 3: these methods will be tested and compared using a cluster randomised controlled trial design, in populations served by defined health centres. Their efficacy will be measured in terms of improvement of the classical TB control programme indicators (cure rate, defaulter rate, failure rate, death rates). The methods will also be evaluated on their acceptability by the TB patients and the communities and on their feasibility (24 months).
Methods of the Intervention Trial:
The intervention is intended to improve access to care and increase adherence to treatment, targeting simultaneously DHC staff, TB patients and communities, and includes four components:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed sputum-smear positive pulmonary TB (at least two positive specimens), aged 15 years or more, and living in the district served by the District Health Centre.
排除标准
- •Smear-negative tuberculosis cases
- •extra-pulmonary tuberculosis cases
- •TB re-treatment cases
结局指标
主要结局
TB treatment success rate (cure + completed treatment)
Treatment defaulting rates
次要结局
- treatment failure rate
- death rate